Legal & Regulatory

The company brings its temperature-controlled Superbox to the US pharma industry, aiming to improve speed, compliance, and resilience in the cold chain process.

The company will participate in the Trump administration’s direct-to-patient drug platform, while committing $100 billion to US R&D and manufacturing.

The pharma giant becomes the latest manufacturer to participate in the Trump Administration’s direct-to-patient pricing platform, aligning US drug costs with European benchmarks while reinforcing its domestic manufacturing investments.

In today’s Pharma Pulse, the FDA clears new denosumab biosimilars for osteoporosis and cancer-related bone loss, while healthcare leaders grapple with a surge in "nuclear verdicts" driven by shifting public sentiment.

With a planned US launch in early 2026, the approval expands treatment options following strong late-stage trial results.

Nine more companies have joined the DTC government-run website, which is set to launch sometime next year.

The South Korea–based CDMO acquires its first US manufacturing facility in Rockville, MD, expanding its global footprint and strengthening biologics capacity.

In today’s Pharma Pulse, major pharma players commit to most-favored-nation pricing, as DHL bolsters West Coast logistics for temperature-sensitive drugs.

In today’s Pharma Pulse, the Senate advances legislation to block "biotechnology companies of concern," clinical research ties COVID-19 to REM-dominant sleep apnea, and a new analysis reveals an affordability breaking point for employer-sponsored health insurance.

In today’s Pharma Pulse, House Republicans block a critical insurance subsidy extension, as new research highlights the oncology benefits of GLP-1s.

The pharmaceutical giant’s new 700,000-square-foot hub aims to onshore production of key medicines and strengthen the US drug supply chain.

In today’s Pharma Pulse, the FDA approves Amgen’s Uplizna (inebilizumab-cdon), the first CD19-targeted therapy for gMG with convenient twice-yearly dosing, and much more.

Welcome to Pharma Pulse, a Pharmaceutical Commerce podcast where we bring you the latest insights shaping patient access, supply chain/logistics, data & tech, and healthcare innovation. I’m your host, and let’s get into today’s headlines.

As the FDA ends its phased exemption period for most trading partners, Two Labs’ Michael Rowe warns that DSCSA compliance is entering a far more complex era—one shaped by real-time traceability, digital record requirements, and a transition to a 12-digit NDC.

In today’s Pharma Pulse, Augmentin XR is the first drug approved under the FDA's new CNPV pilot program and much more.

In today’s Pharma Pulse, the University of Maryland expands its medical class to combat physician shortages and much more.

In today’s Pharma Pulse, the ACIP votes to end the decades-long universal hepatitis B birth dose recommendation; meanwhile, former FDA commissioners warn that new vaccine policies are compromising the long-standing regulatory framework and jeopardizing public health security.

In today’s Pharma Pulse, Dr. Richard Pazdur retires from his CDER director role weeks after his appointment, and much more.

The new 350,000 square-foot Mesa hub is expected to expand the compounding pharmacy’s national fulfillment and advanced compounding capabilities.

In today’s Pharma Pulse, a US-UK trade agreement mandates that the UK’s NICE agency raises its QALY threshold, increasing access to innovative drugs and much more.

The agreement includes exemptions for UK-produced drugs and medical devices from Section 232 tariffs, but mandates a significant change to the UK's NICE value appraisal framework.

In the second part of his Pharma Commerce video interview, Dan Walles, VP & GM, traceability and compliance solutions, TraceLink, describes how initial EPCIS setup issues quickly give way to operational challenges—missing data, mismatched shipments, and suspect product alerts. Dispensers that succeed are the ones developing repeatable, cross-partner exception workflows.

The Trump administration has announced new negotiated Medicare prices for a second wave of blockbuster treatments, yielding an estimated $12 billion in savings for 2027, when compared to Medicare’s 2024 net spending.

In the first part of his Pharma Commerce video interview, Dan Walles, VP & GM, traceability and compliance solutions, TraceLink, notes that full readiness hinges on integrating serialized data exchange into everyday operations, not simply meeting minimum compliance requirements.

In today’s Pharma Pulse, the federal government prepares to unveil newly negotiated Medicare prices for 15 high-cost drugs, while Novartis receives FDA approval for Itvisma, a one-time gene therapy offering a new treatment pathway for older children and adults with spinal muscular atrophy.